MAUDE Adverse Event Report: ZIMMER GMBH NCB, FEMUR PLATE, LEFT, 9 HOLES, 246 MM; NCB FEMORAL PLATES

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products - therapy date: (b)(6) 2014.The manufacturer did not receive devices, x-rays, or other source documents for review.As no lot numbers were provided for the devices, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer¿s reference number of this file is (b)(4).
Event or Problem Description
Patient was implanted on left side and revised due to pain, implant fracture.
Additional Manufacturer Narrative
Investigation results were made available.Additional: d4, h2, h4, h6; correction: b4, b5, d10, g4, g7, h3, h10.Dhr review: ref#: (b)(4), lot#: 2837247.- yield: (b)(4).- delivered: (b)(4).The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trigger considering the following event is identified: medical : revision due to implant fracture.Event description: it was reported that the patient has been implanted with ncb femur plate and revised on (b)(6) 2018 date due to implant fracture.Review of received data: - x-rays reviewed: left tight with kee joint ap-view: total knee replacement without signs of loosening.Situation after plate osteosynthesis of a periprosthetic supracondylar femur fracture (rorabeck-classification ii°) with breakage of the plate.Beginning callus formation lateral and medial.Bony fragments.Left distal tight with kee joint lateral-view: supracondylar femur fracture dislocated.Breakage of the plate in the area of a screw hole by an inserted screw.The fracture edges of the distal fragment are slightly sclerosed, no evidence of bone fracture healing in the area of the central fracture area of the proximal fragment, the fracture edge is shown out of focus.Devices analysis: - visual examination: the broken plate was available for material analysis.The sub components (screws) have not been returned.A visual examination was performed.The fracture of the plate is located through the eighth screw hole.On the fracture surfaces there are small polished areas, most probably due to contact between the parts after the fracture.There are several scratches available on the outer surface of the plate.On the non-bone facing side of the plate, several spot-like discolorations can be seen.These can probably be attributed to the use of an electrosurgical instrument (cauter) during surgery.Based on this visual examination, the reported event can be confirmed.Review of product documentation: - this device is intended for treatment.Conclusion summary: it was reported that the patient has been implanted with ncb femur plate and revised on (b)(6) 2018 due to implant fracture.Therefore, the in vivo time is unknown.The device manufacturing quality records indicate that the ncb plate met all requirements to perform as intended.According to the received x-rays it can be said that the plate was implanted not too long ago because a callus formation lateral and medial can be seen.There are no signs of fracture healing.The visual examination of the plate indicates that no material defects that could have triggered the fracture could be detected.There are several factors which may have contributed to the plate breakage.It can be that the plate was over stressed during the in vivo time or a wrong patient behavior can also be the cause for the breakage.The investigation results did not identify a non-conformance or a complaint out of box (coob).However, based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
Event or Problem Description
Investigation results are now available.

• Brand Name: NCB, FEMUR PLATE, LEFT, 9 HOLES, 246 MM
• Common Device Name: NCB FEMORAL PLATES
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8159809
• Report Number: 0009613350-2018-01232
• Device Sequence Number: 11312092
• Product Code: HRS
• UDI-Device Identifier: 00889024297401
• UDI-Public: 00889024297401
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K042695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 02.03260.109
• Device Lot Number: 2837247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/21/2018
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention